A Phase 2 interventional study of anti-thymocyte globulin and Fludarabine in Kidney Transplantation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
The primary objective of this study is to assess the ability of bone marrow transplantation (BMT) and high-dose post-transplantation cyclophosphamide (PT/Cy) to induce renal allograft tolerance and thus enable discontinuation of immunosuppressive therapy in haploidentical living related donor renal transplant recipients.
Transplantation is a good treatment for people with end-stage kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. Unless a person receiving a kidney from someone else takes drugs that reduce immune function, the kidney will be rejected. Those drugs must be continued life-long and cause many issues. Therefore, tolerance of the transplanted kidney, without chronic rejection and without the need for permanent immunosuppressive drug treatment, is a highly desirable goal. If this can be achieved, it would make "one kidney for life" possible.
The study treatment includes several days of study medications followed by a kidney and bone marrow transplant. After the transplant, the study treatment will continue with a few more doses of study medications and then anti-rejection medication is started. After a while, the anti-rejection medication is slowly stopped. Researchers will examine blood and tissue samples and try to identify genetic markers for certain conditions like chimerism, response to therapy, and tolerance.
*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recipient participants must meet all of the following criteria to be eligible for this study:
Donor participants must meet all of the following criteria to be eligible for this study:
Exclusion Criteria:
Recipient subjects who meet any of the following criteria will not be eligible for this study:
Underlying renal disease with a high risk of disease recurrence in the transplanted kidney, including:
Subjects demonstrating any one of the following will be excluded:
Donor subjects who meet any of the following criteria will not be eligible for this study:
Subjects demonstrating any one of the following will be excluded:
Reduced-intensity conditioning regimen (RICG), bone marrow transplantation (BMT), high dose post-transplant cyclophosphamide (PT/Cy) and Standard of Care (SOC). Participants will receive: ATG (pre-transplant), pre-medicated with acetaminophen, diphenhydramine; steroid taper of methylprednisolone; fludarabine (2-6 days before transplant), and low-dose cyclophosphamide (pre- transplant); total body irradiation the day before transplant. Participants will receive a living renal transplant followed by BMT. High-dose cyclophosphamide will be given on days 3 and 4 post-transplant with MESNA. Filgrastim will be given on day 5 post-transplant and continue until absolute neutrophil recovery. Standard immunosuppression of tacrolimus, MMF, and prednisone will begin on day 5 post-transplant and be given ≥26 weeks post-transplant. Eligible participants will be gradually withdrawn from medication over a period of 24-40 weeks.
Biological: anti-thymocyte globulin · Drug: Fludarabine · Drug: Cyclophosphamide · Radiation: Total Body Irradiation · Drug: acetaminophen · Drug: diphenhydramine · Drug: methylprednisolone · Biological: bone marrow transplant · Drug: MESNA · Drug: mycophenolate mofetil · Drug: prednisone · Drug: filgrastim
An initial dose of 0.5 mg/kg IV will be administered over 6 hours on Day -9. Thereafter the daily dose will be increased to 2 mg/kg IV given over 4 hours on Days -8 and -7. No more than 150 mg of ATG may be administered per day.
Also known as: ATG, Thymoglobulin
Fludarabine at dose 30 mg/m\^2 will be administered daily by intravenous infusion over 30 minutes on Day -6 to Day -2.
1. Low dose pre-transplant cyclophosphamide will be administered intravenously (IV) over 1- 2 hours, (depending on volume) on Days -6 and -5. The dose of pre-transplant cyclophosphamide is 14.5 mg/kg/day. 2. High dose cyclophosphamide \[50mg/kg (Ideal Body Weight)\] will be administered on Day 3 post-transplant (within 60 to 72 hours of marrow infusion) and on Day 4 post-transplant. Cyclophosphamide will be given IV over 1-2 hours depending on volume.
Also known as: cytoxan
Total body irradiation, consisting of 200 centigray (cGy) Anterior-Posterior/Posterior-Anterior (AP/PA) with 4 Megavolts (MV) or 6 MV photons at 8-12 cGy/min at the point of prescription will be administered in a single day on Day -1.
Also known as: TBI
650 mg orally prior to antithymocyte globulin infusion.
Also known as: Tylenol
25mg diphenhydramine orally prior to antithymocyte globulin infusion.
Also known as: benadryl
On Days -9 to -7 methylprednisolone 1mg/kg IV 1 hour prior ATG. This dose may be repeated once 3 hours after the first dose of steroids. On Day -6 and -5, methylprednisolone 0.75 mg/kg/ IV as a single dose; on Days -4 and -3, methylprednisolone 0.5 mg/kg/ IV as a single dose; on Day -2 methylprednisolone 0.25 mg/kg/ IV as a single dose.
Unprocessed, unmanipulated bone marrow will be harvested from the donor and infused into the recipient on Day 0.
Also known as: bone marrow transfusion, BMT
A series of MESNA doses will be administered for each dose of high dose, post-transplant cyclophosphamide. The total daily dose of MESNA is equal to 80% of the total daily dose of cyclophosphamide.
Also known as: Mesnex
MMF will be administered at a dose of 15 mg/kg orally three times per day based upon actual body weight, with the maximum of 3 grams a day from Day 5 to 35. The dose will then be reduced to the standard 1 g twice daily thereafter.
Also known as: MMF, CellCept
Prednisone will be administered at a dose of 10 mg orally daily from Day 5 for 12 weeks. Thereafter the dose will be reduced to 5 mg orally daily.
All recipients will receive 5 microgram/kg per day of filgrastim as a single, subcutaneous injection from Day 5 post-transplant until the absolute neutrophil count is greater than 1000/µl on three consecutive measurements over at least 2 days.
Also known as: neupogen
Percent of Participants Who Achieved Operational Tolerance
Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Time frame: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression
Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells.
Time frame: Transplant to Two Years Post-Transplant
Severity of Graft-versus-Host Disease in Transplanted Participants
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Severity of GVHD is based on skin, liver, and intestinal tract symptoms, ranging from I to IV, with IV being the worst. This measure counts the number of participants experiencing GVHD by severity.
Time frame: Transplant to Two Years Post-Transplant
Duration in Days of Graft-versus-Host Disease in Transplanted Participants
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event.
Time frame: Transplant to Two Years Post-Transplant
Number of Transplanted Participants With Engraftment Syndrome
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Duration in Days of Engraftment Syndrome in Transplanted Participants
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil count ≥ 500 per µL), without apparent other cause. Duration (in days) is measured as the time from the start of the engraftment syndrome event to the end of the engraftment syndrome event.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Number of Transplanted Participants Who Died
Number of participant deaths after receiving a transplant per protocol.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Number of Transplanted Participants With Acute Renal Allograft Rejection
Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven.
Time frame: Transplant to End of Study (Up to 25 months After Enrollment)
Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy.
Time frame: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0.
Time frame: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation.
Time frame: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)
Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.
Time frame: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)
Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.
Time frame: Transplant to End of Study (Up to 25 months)
Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher.
Time frame: Post-Transplant Neutrophil Nadir to Neutrophil Recover
Number of Days From Transplant to Platelet Count Recovery
Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood.
Time frame: Transplant to Platelet Count Recovery
Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal.
Time frame: Transplant to 52 Weeks after Discontinuation of All Immunosuppression
Number of Participants Free From Return to Immunosuppression for the Duration of the Study
Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study.
Time frame: Transplant to End of Study (Up to 25 Months)
| Milestone | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|---|
| Started | 2 | 1 | 1 |
| Completed | 0 | 1 | 0 |
| Not completed | 2 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Decision by study sponsor or regulatory | 2 | 0 | 0 |
Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
| Percent of participants | Enrolled, Transplanted |
|---|---|
| Percent of Participants Who Achieved Operational Tolerance | 0 (0 to 97.5) |
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant | 1 |
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Severity of GVHD is based on skin, liver, and intestinal tract symptoms, ranging from I to IV, with IV being the worst. This measure counts the number of participants experiencing GVHD by severity.
| Participants | Enrolled, Transplanted |
|---|---|
| Grade I | 1 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event.
| Days | Enrolled, Transplanted |
|---|---|
| Duration in Days of Graft-versus-Host Disease in Transplanted Participants | 7 ± NA |
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants With Engraftment Syndrome | 0 |
Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil count ≥ 500 per µL), without apparent other cause. Duration (in days) is measured as the time from the start of the engraftment syndrome event to the end of the engraftment syndrome event.
No measurements were reported for this outcome.
Number of participant deaths after receiving a transplant per protocol.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants Who Died | 1 |
Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants With Acute Renal Allograft Rejection | 1 |
This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection.
| participants | Enrolled, Transplanted |
|---|---|
| Acute Cellular Rejection Banff Grade IA | 0 |
| Acute Cellular Rejection Banff Grade IB | 0 |
| Acute Cellular Rejection Banff Grade IIA | 0 |
| Acute Cellular Rejection Banff Grade IIB | 0 |
| Acute Cellular Rejection Banff Grade III | 0 |
| Acute Antibody Mediated Rejection | 0 |
Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection | 1 |
Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven.
| Days | Enrolled, Transplanted |
|---|---|
| Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment | 23 ± NA |
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy.
| Events | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|
| Infection | 0 | 2 |
| Wound complications | 0 | 0 |
| Post-transplant diabetes | 0 | 0 |
| Hemorrhagic cystitis | 0 | 0 |
| Malignancy | 0 | 0 |
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0.
| Events | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|
| Grade 1 | 0 | 0 |
| Grade 2 | 0 | 0 |
| Grade 3 | 0 | 2 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation.
| Days | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|
| Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy | — | 9.5 ± 2.12 |
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal | 0 |
Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation | 0 |
Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher.
| Days | Enrolled, Transplanted |
|---|---|
| Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery | 15 ± NA |
Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood.
| Days | Enrolled, Transplanted |
|---|---|
| Number of Days From Transplant to Platelet Count Recovery | 36 ± NA |
Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed | 0 |
Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study.
| Participants | Enrolled, Transplanted |
|---|---|
| Number of Participants Free From Return to Immunosuppression for the Duration of the Study | 0 |
Collected over First study medication dosing through end of study (up to 25 months after enrollment). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled, Not Transplanted | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) |
| Enrolled, Transplanted | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Event | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|
| Benign intracranial hypertensionNervous system disorders | 0/1 | 1/1 |
| InfectionInfections and infestations | 0/1 | 1/1 |
| SinusitisInfections and infestations | 0/1 | 1/1 |
| Shock haemorrhagicVascular disorders | 0/1 | 1/1 |
| Tibia fractureInjury, poisoning and procedural complications | 1/1 | 0/1 |
| Event | Enrolled, Not Transplanted | Enrolled, Transplanted |
|---|---|---|
| Blood creatinine increasedInvestigations | 0/1 | 1/1 |
| Acute graft versus host disease in skinImmune system disorders | 0/1 | 1/1 |
Enrolled participants
| Age, Categorical(Participants) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 1 | 4 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| Female | 1 | 0 | 1 | 2 |
| Male | 1 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 1 | 0 | 1 | 2 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| United States | 2 | 1 | 1 | 4 |
| Serum Creatinine(mg/dL) | Enrolled, Screen Failure | Enrolled, Not Transplanted | Enrolled, Transplanted | Total |
|---|---|---|---|---|
| Mean | NA ± NA | NA ± NA | 2.1 ± NA | 2.1 ± NA |
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National Institute of Allergy and Infectious Diseases (NIAID)